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Session 8: Streamlining and Harmonizing Biosimilar Development
Session Chair(s)
Christopher J. Webster, DVM, PhD, MS, MSc
Principal, BioApprovals, United States
Vast experience has been gained in the development of biosimilars over the past decade, which can enable the streamlining of biosimilar developments by allowing specific reductions of regulatory requirements without compromising the quality or safety of the product. Moreover, there is a broad interest of patients that such opportunities are pursued vigorously, as the elimination of unnecessary regulatory requirements contributes to competition within the biosimilars’ market and the eventual affordability of, and access to, biosimilars. This session will examine new proposals for streamlining the development of biosimilars and consider the circumstances under which such new approaches might be introduced and the issues to be confronted in harmonizing these approaches across the world.
Learning Objective : Upon completion of this session, the participant should be able to:- Be aware of potential new directions for the evolution of regulatory requirements for the development of biosimilars and the scientific bases for them
- Understand how such new regulatory requirements might be introduced into current development paradigms
- Be able to design efficient global development plans for biosimilars taking advantage of new regulatory approaches
Speaker(s)
Efficient Development of Biosimilars: A Rumsfeldian Approach
Christopher J. Webster, DVM, PhD, MS, MSc
Principal, BioApprovals, United States
Tailored Clinical Biosimilar Development
Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz GmbH, Austria
Update on the WHO Pilot Procedure for Prequalification of BTPs: Rituximab and Trastuzumab
Guido Pante, PhD
Technical Officer, World Health Organization , Switzerland
Panel Discussion: Streamlining Global Biosimilar Development
Guido Pante, PhD
Technical Officer, World Health Organization , Switzerland
Panel Discussion: Streamlining Global Biosimilar Development
Martin Schiestl, PhD
Global Head Regulatory Affairs Policy, Sandoz GmbH, Austria
Panel Discussion: Streamlining Global Biosimilar Development
Christopher J. Webster, DVM, PhD, MS, MSc
Principal, BioApprovals, United States
Panel Discussion: Streamlining Global Biosimilar Development
Elena Wolff-Holz, MD, PhD
Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor, Paul-Ehrlich Institut, Germany
Panel Discussion: Streamlining Global Biosimilar Development
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States